Author:
Tsamandouras Nikolaos,Duvvuri Sridhar,Riley Steve
Publisher
Springer Science and Business Media LLC
Reference7 articles.
1. FDA (2005) Guidance for Industry. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Silver Spring
2. Darpo B, Benson C, Dota C, Ferber G, Garnett C, Green C, Jarugula V, Johannesen L, Keirns J, Krudys K, Liu J, Ortemann-Renon C, Riley S, Sarapa N, Smith B, Stoltz R, Zhou M, Stockbridge N (2015) Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase. Clin Pharmacol Ther 97(4):326–335.
https://doi.org/10.1002/cpt.60
3. FDA (2017) E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs—questions and answers (R3). Guidance for Industry, SIlver Spring
4. Garnett C, Bonate PL, Dang Q, Ferber G, Huang D, Liu J, Mehrotra D, Riley S, Sager P, Tornoe C, Wang Y (2018) Scientific white paper on concentration-QTc modeling. J Pharmacokinet Pharmacodyn 45(3):383–397.
https://doi.org/10.1007/s10928-017-9558-5
5. Garnett C, Needleman K, Liu J, Brundage R, Wang Y (2016) Operational characteristics of linear concentration-QT models for assessing QTc interval in the thorough QT and phase I clinical studies. Clin Pharmacol Ther 100(2):170–178.
https://doi.org/10.1002/cpt.361
Cited by
2 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献